DNDi Template Development Collaboration and License Agreement

Protecting & sharing information | Technology transfer

Summary of Approaches

What is included in the technology and/or materials to be transferred?
- Manufacturing Technology to be transferred will include a non-exclusive, royalty-free license in all partner technology that is useful or necessary for the manufacture of the product.
What are the responsibilities of each party to in relation to the transfer of materials and/or technology?
- The partner must disclose all Manufacturing Technology to enable to the transferee to manufacture the product at a location designated by the transferee.
- The partner must also provide reasonably requested assistance, including onsite assistance, free-of-charge.

Annotations

This template Development Collaboration and License Agreement (“DCLA”) was published by DNDi alongside a paper in the Journal of Intellectual Property Law and Practice which explains the rationale for some key provisions. The paper also includes examples of DNDi’s approaches to negotiating the template language, recognizing the importance of adapting provisions for different contexts.

The DCLA is intended for collaboration on activities from Phase 1 clinical trials through to proof of concept in humans. DNDi may enter into a DCLA as a follow-on from an initial Research Collaboration and License Agreement, or as a standalone development collaboration. The parties will undertake a Development and Distribution Program including clinical development, manufacturing and distribution of a product for treatment of specified disease(s) (“Field”). Distribution will be on an Affordable Basis in all countries in which one or more of the diseases of the Field is endemic (“Territory”).

The parties will draw-up a high level Access and Implementation Plan at the start of the program and establish detailed plans on a country level upon agreement of a Regulatory Strategy for a particular country. The parties will also prepare a product needs forecast for the Territory which will be used to inform the Access and Implementation Plan and the Regulatory Strategy.

The DCLA includes mutual license grants between the parties under background and foreground intellectual property. The licenses are non‐exclusive, worldwide, perpetual, irrevocable, fully paid, royalty‐free and sublicensable. The licenses may be used for the performance of the Development and Distribution Program, as well as for other non-commercial research purposes. The partner may also commercialize the product in the Field outside of the Territory, as long as it is at a price that allows a purchaser to buy the product in sufficient quantity to meet public health or individual needs. The partner may only grant sublicenses if the sublicense undertakes to commercialize the product on an Affordable Basis in the Territory.

Provision Language

ANNEX 6 – TECHNOLOGY TRANSFER

1. Partner shall grant to any third party manufacturer (each manufacturer, a “Technology Transferee”) a non-exclusive, royalty-free license under Partner’s rights to and interest in all Technology controlled by Partner that is necessary or useful for the manufacture of the Product (such Technology, the “Manufacturing Technology”).

2. Partner shall disclose to each Technology Transferee all Manufacturing Technology so as to enable such Technology Transferee to manufacture the Product at facilities designated by such Technology Transferee.

3. Partner shall provide technical assistance (including on.site assistance) to each Technology Transferee, free of charge, as reasonably requested by such Technology Transferee in connection with the transfer of the Manufacturing Technology

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DNDi Template Development Collaboration and License Agreement

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Master Alliance Provisions Guide (MAPGuide)

DNDi Template Development Collaboration and License Agreement

Provision Language

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Get In Touch

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Contact Us

Get In Touch

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